Critical Illness Outcomes Study

• Conditions: Intensive Care; Intensive Care Unit; Critical Illness

• Registration Number: NCT01109719
• Lead Sponsor: National Institute of General Medical Sciences (NIGMS)

Brief Summary

We will test whether the way that an intensive care unit is organized can influence patient related outcomes such as mortality. We will test whether who works in the ICU, and how the ICU is managed will affect the care received by patients. The primary study hypothesis is whether the number of clinical protocols present in an intensive care unit is linked to patient mortality

Detailed Description

Title: Do ICU Structural and Procedural Factors Influence Patient Related Outcomes: The Critical Illness Outcome Study (CIOS)

Objectives: This is an exploratory ecologic study designed to examine the organizational and structural factors present in adult intensive care units in the United States. A second objective is to determine whether these organizational and structural factors are associated with patient related outcomes. In addition, we intend to examine whether these organizational and structural issues are associated with patient treatments.

Hypotheses: (Ho) A. The number of protocols used in an ICU is inversely associated with ICU and hospital survival for critically ill patients.

B. Compliance with disease specific protocols is not independently associated with hospital survival for critically ill patients

Specific Aims

1. To describe the organizational structure of participating intensive care units

2. To determine whether the number of protocols used in an intensive care unit is associated with ICU and hospital survival for critically ill patients

3. To determine the frequency with which ICU's follow disease specific protocols for patients with sepsis and ALI

Study Design

1. Prospective ecologic study of 50-60 adult intensive care units and admitted patients

2. ICU organizational and structural data will be collected for each participating ICU

3. 125-200 adult patients in each intensive care unit will be enrolled. Patients within the ICU on a varying, specific day each week will be included. Demographic and treatment variables will be collected for that day on that patient. Outcome data will be collected on ICU and hospital discharge.

Study Timeline

• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Study Start: 2010-07
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-23
• Last Update Posted: 2010-08-25
• Primary Completion: 2011-02
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

• Hospitalized adult patient in a study ICU on the date of data collection. This includes patients who may be in ICU despite not having critical illness for reasons such as lack of floor beds.

Exclusion Criteria

1. Patient enrolled on previous study collection day 2 Previous enrollment into other study ICU 3. Age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In Patient Mortality	Hospital discharge or 60 days

Secondary Outcome Measures

Name	Time	Method
2. Mortality prior to ICU discharge 3. Length of ICU stay 4. Length of hospital stay ICU mortality	ICU discharge or 60 days
ICU length of stay	ICU discharge or 60 days
Length of hospital stay	Hospital discharge or 60 days

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States